Identity
- Trade Name
- Sure-Vue Adeno Test FDA UDI
- Generic Name
- Adenovirus antigen IVD, kit, rapid ICT, clinical FDA UDI
- Device Name
- Sure-Vue® Adeno Test is a membrane-based immunogold assay for the detection of adenovirus and adenovirus antigens. The test is a rapid visual test for the qualitative detection of adenovirus serotypes present in eye swabs, nasal and pharyngeal secretions, fecal samples, and cell culture supernatant. This test is for professional use only. FDA UDI
- Model / Reference
- 067020 FDA UDI
- Description
- Sure-Vue® Adeno Test is a membrane-based immunogold assay for the detection of adenovirus and adenovirus antigens. The test is a rapid visual test for the qualitative detection of adenovirus serotypes present in eye swabs, nasal and pharyngeal secretions, fecal samples, and cell culture supernatant. This test is for professional use only. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00780311000509 FDA UDI
- GMDN Term
- Adenovirus antigen IVD, kit, rapid ICT, clinical FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Adenovirus antigen IVD, kit, rapid ICT, clinical
Sure-Vue Adeno Test by Sa Scientific, Ltd — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Adenovirus antigen IVD, kit, rapid ICT, clinical.
- Rapid Response — BTNX Inc · Class I
- Adenovirus Antigen Detection Kit (Immunochromatography) — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Class I
- Adenovirus Antigen Detection Kit (Immunochromatography) — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. · Class I
- AdenoPlus — Quidel Corp. · Class I
- SAS Adeno Test — SA SCIENTIFIC, LTD
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Sa Scientific, Ltd
Sources (1)
- FDA UDI aa20cce2-50c4-46c7-b7bd-bb3eefbd98c7 33 fields · synced Jun 8, 2026